Cleared Traditional

KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS

K950999 · Buckman Co., Inc. · Orthopedic
Jan 1996
Decision
328d
Days
Class 2
Risk

About This 510(k) Submission

K950999 is an FDA 510(k) clearance for the KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS, a Orthosis, Spondylolisthesis Spinal Fixation (Class II — Special Controls, product code MNH), submitted by Buckman Co., Inc. (Concord, US). The FDA issued a Cleared decision on January 25, 1996, 328 days after receiving the submission on March 3, 1995. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K950999 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 1995
Decision Date January 25, 1996
Days to Decision 328 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MNH — Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3070